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FDA Updates

Latest News

FDA building
News
01/28/2025
Meagan Thistle
The FDA has approved a supplemental biologics license application for lecanemab-irmb (Leqembi, Eisai Co., Ltd.; Biogen Inc.), an intravenous treatment (IV) for early Alzheimer disease (AD).
The FDA has approved a supplemental biologics license application for lecanemab-irmb (Leqembi, Eisai Co., Ltd.; Biogen Inc.), an intravenous treatment (IV) for early Alzheimer disease (AD).
The FDA has approved a...
01/28/2025
Psych Congress Network
US FDA sign
News
01/10/2025
Brionna Mendoza
Posdinemab, a phosphorylated tau-directed monoclonal antibody (mAb) being studied for the treatment of early Alzheimer disease (AD), was granted Fast Track designation by the US Food and Drug Administration (FDA).
Posdinemab, a phosphorylated tau-directed monoclonal antibody (mAb) being studied for the treatment of early Alzheimer disease (AD), was granted Fast Track designation by the US Food and Drug Administration (FDA).
Posdinemab, a phosphorylated...
01/10/2025
Psych Congress Network
Increase in Suicidality Associated With FDA Black Box Warning Implementation
News
10/11/2024
Evi Arthur
Black box warnings on antidepressants from the FDA warning of increased risk of suicidality were associated with a decline in mental health treatment and an increase in suicide attempts and deaths in young people, according to a systematic...
Black box warnings on antidepressants from the FDA warning of increased risk of suicidality were associated with a decline in mental health treatment and an increase in suicide attempts and deaths in young people, according to a systematic...
Black box warnings on...
10/11/2024
Psych Congress Network
FDA approval featuring craig chepke
News
09/27/2024
Meagan Thistle
The US Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults.
The US Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) capsules for oral use for the treatment of schizophrenia in adults.
The US Food and Drug...
09/27/2024
Psych Congress Network
fda building sign
News
08/16/2024
Brionna Mendoza
The US Food and Drug Administration (FDA) last week rejected the new drug application (NDA) from Lykos Therapeutics for midomafetamine (MDMA) capsules for the treatment of post-traumatic stress disorder (PTSD) in conjunction with...
The US Food and Drug Administration (FDA) last week rejected the new drug application (NDA) from Lykos Therapeutics for midomafetamine (MDMA) capsules for the treatment of post-traumatic stress disorder (PTSD) in conjunction with...
The US Food and Drug...
08/16/2024
Psych Congress Network
FDA Considers Supplemental NDA for Brexpiprazole Plus Sertraline for PTSD
News
07/24/2024
Jolynn Tumolo
The US Food and Drug Administration recently accepted a supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with PTSD, announced codevelopers Otsuka Pharmaceutical Co. Ltd. and H....
The US Food and Drug Administration recently accepted a supplemental New Drug Application for brexpiprazole in combination with sertraline for the treatment of adults with PTSD, announced codevelopers Otsuka Pharmaceutical Co. Ltd. and H....
The US Food and Drug...
07/24/2024
Psych Congress Network
FDA building sign
News
07/23/2024
Brionna Mendoza
The US Food and Drug Administration (FDA) has again declined Swedish drug manufacturer Orexo’s New Drug Application (NDA) for OX125, a high-dose naloxone nasal spray for opioid overdose reversal.
The US Food and Drug Administration (FDA) has again declined Swedish drug manufacturer Orexo’s New Drug Application (NDA) for OX125, a high-dose naloxone nasal spray for opioid overdose reversal.
The US Food and Drug...
07/23/2024
Psych Congress Network
lab work
News
07/08/2024
Jolynn Tumolo
A pharmacokinetics study of AD04, a potential treatment for AUD, is designed to meet an FDA requirement for an upcoming phase 3 trial and is expected to last 6 months.
A pharmacokinetics study of AD04, a potential treatment for AUD, is designed to meet an FDA requirement for an upcoming phase 3 trial and is expected to last 6 months.
A pharmacokinetics study of...
07/08/2024
Psych Congress Network
Video Game Treatment for Adults With ADHD Cleared by FDA
News
07/02/2024
Evi Arthur
AKL-T01 is indicated for adults with primarily inattentive or combined-type ADHD who have a demonstrated attention issue.
AKL-T01 is indicated for adults with primarily inattentive or combined-type ADHD who have a demonstrated attention issue.
AKL-T01 is indicated for adults...
07/02/2024
Psych Congress Network
FDA Approves First Liquid, Non-Stimulant for Pediatric ADHD
News
06/11/2024
Evi Arthur
The FDA approved Tris Pharma, Inc.’s ONYDA™ XR (clonidine hydrochloride), a once-daily extended-release oral suspension medication, for the treatment of ADHD in patients 6 years and older.
The FDA approved Tris Pharma, Inc.’s ONYDA™ XR (clonidine hydrochloride), a once-daily extended-release oral suspension medication, for the treatment of ADHD in patients 6 years and older.
The FDA approved Tris Pharma,...
06/11/2024
Psych Congress Network
Study on MDD - stock image
News
03/24/2025
Jolynn Tumolo
Plans have been announced for a phase II clinical study of investigational lithium therapy AL001 for MDD, focusing on its unique properties and its effect on lithium delivery in the brain compared with marketed lithium salts.
Plans have been announced for a phase II clinical study of investigational lithium therapy AL001 for MDD, focusing on its unique properties and its effect on lithium delivery in the brain compared with marketed lithium salts.
Plans have been announced for a...
03/24/2025
Psych Congress Network
US FDA sign
News
03/24/2025
Jolynn Tumolo
To avoid misperceptions that current labeling for buprenorphine-containing transmucosal products includes a maximum daily dose, the US Food and Drug Administration (FDA) is encouraging the submission of supplemental new drug applications to...
To avoid misperceptions that current labeling for buprenorphine-containing transmucosal products includes a maximum daily dose, the US Food and Drug Administration (FDA) is encouraging the submission of supplemental new drug applications to...
To avoid misperceptions that...
03/24/2025
Psych Congress Network
3 medical professionals stand together talking in the hallway of a medical facility
News
03/21/2025
Jolynn Tumolo
A novel 78-minute accelerated theta-burst stimulation (aTBS) protocol reduced depression severity in patients with treatment-resistant depression (TRD), according to results from a randomized clinical trial published in JAMA Psychiatry.
A novel 78-minute accelerated theta-burst stimulation (aTBS) protocol reduced depression severity in patients with treatment-resistant depression (TRD), according to results from a randomized clinical trial published in JAMA Psychiatry.
A novel 78-minute accelerated...
03/21/2025
Psych Congress Network
an older man wearing glasses rubs his face in stress tired depression treatment resistant depression
News
03/18/2025
Jolynn Tumolo
A genetic predisposition to traits including neuroticism, cognitive function, and sleep patterns were significantly associated with the development of treatment-resistant depression (TRD) in a cohort study published in JAMA Psychiatry.
A genetic predisposition to traits including neuroticism, cognitive function, and sleep patterns were significantly associated with the development of treatment-resistant depression (TRD) in a cohort study published in JAMA Psychiatry.
A genetic predisposition to...
03/18/2025
Psych Congress Network
Woman sitting at bar holding a drink.
News
03/13/2025
Jolynn Tumolo
Nine weeks of low-dose semaglutide decreased the amount of alcohol consumed, relative to placebo, in a laboratory test involving adults with AUD who were not seeking treatment, study finds.
Nine weeks of low-dose semaglutide decreased the amount of alcohol consumed, relative to placebo, in a laboratory test involving adults with AUD who were not seeking treatment, study finds.
Nine weeks of low-dose...
03/13/2025
Psych Congress Network
emergency room hospital waiting room reception area
News
03/12/2025
Jolynn Tumolo
Barriers may be hampering the use of medications for opioid use disorder (MOUD) in US emergency departments (EDs), according to results from a systematic review published in the Journal of Substance Use & Addiction Treatment.
Barriers may be hampering the use of medications for opioid use disorder (MOUD) in US emergency departments (EDs), according to results from a systematic review published in the Journal of Substance Use & Addiction Treatment.
Barriers may be hampering the...
03/12/2025
Psych Congress Network
stethoscope  with research images in background medical study clinical trial research
News
03/12/2025
Jolynn Tumolo
Machine learning models used routine clinical data from electronic health records to predict progression to schizophrenia and bipolar disorder within 5 years for patients with pre-existing mental illness, according to a study published in...
Machine learning models used routine clinical data from electronic health records to predict progression to schizophrenia and bipolar disorder within 5 years for patients with pre-existing mental illness, according to a study published in...
Machine learning models used...
03/12/2025
Psych Congress Network
two researchers look at computer screen in lab medical research
News
03/05/2025
Jolynn Tumolo
More than 5 years of continuous treatment with dopamine D2 receptor-blocking long-acting injectable (LAI) antipsychotics does not appear to increase the risk of breakthrough psychosis in patients with first-episode schizophrenia.
More than 5 years of continuous treatment with dopamine D2 receptor-blocking long-acting injectable (LAI) antipsychotics does not appear to increase the risk of breakthrough psychosis in patients with first-episode schizophrenia.
More than 5 years of continuous...
03/05/2025
Psych Congress Network
A doctor and patient talk
News
03/04/2025
Jolynn Tumolo
In older adults with normal cognition, depressive symptoms were not consistently associated with amyloid pathology. Meanwhile, depressive symptoms were associated with a reduced likelihood of amyloid pathology in older adults with mild...
In older adults with normal cognition, depressive symptoms were not consistently associated with amyloid pathology. Meanwhile, depressive symptoms were associated with a reduced likelihood of amyloid pathology in older adults with mild...
In older adults with normal...
03/04/2025
Psych Congress Network
A woman lies on the couch holding an ice pack to her head
News
03/03/2025
Jolynn Tumolo
Mild traumatic brain injury (mTBI) that occurred in the context of psychological trauma was associated with poorer long-term outcomes, including greater posttraumatic stress disorder (PTSD) severity, postconcussive symptoms, and disability.
Mild traumatic brain injury (mTBI) that occurred in the context of psychological trauma was associated with poorer long-term outcomes, including greater posttraumatic stress disorder (PTSD) severity, postconcussive symptoms, and disability.
Mild traumatic brain injury...
03/03/2025
Neurology

Exclusives

andrew penn
Videos
07/01/2024
Andrew Penn, RN, MS, NP, CNS, APRN-BC
Andrew Penn, MS, PMHNP, discusses the recent vote by the FDA's advisory committee (PDAC) against an MDMA-based therapy for the treatment of PTSD in adults and sheds light on what this means for the future of PTSD treatment.
Andrew Penn, MS, PMHNP, discusses the recent vote by the FDA's advisory committee (PDAC) against an MDMA-based therapy for the treatment of PTSD in adults and sheds light on what this means for the future of PTSD treatment.
Andrew Penn, MS, PMHNP,...
07/01/2024
Psych Congress Network
andrew penn
Videos
06/21/2024
Andrew Penn, MS, PMHNP, discusses the recent vote by the FDA's advisory committee (PDAC) against an MDMA-based therapy for the treatment of PTSD in adults and sheds light on what this means for the future of PTSD treatment.
Andrew Penn, MS, PMHNP, discusses the recent vote by the FDA's advisory committee (PDAC) against an MDMA-based therapy for the treatment of PTSD in adults and sheds light on what this means for the future of PTSD treatment.
Andrew Penn, MS, PMHNP,...
06/21/2024
Psych Congress Network
Thomas L. Schwartz, MD
Q&As
03/18/2025
Thomas L. Schwartz, MD, explores medicine’s evolving understanding of insomnia, narcolepsy, and idiopathic hypersomnia from a neuroscientific perspective.
Thomas L. Schwartz, MD, explores medicine’s evolving understanding of insomnia, narcolepsy, and idiopathic hypersomnia from a neuroscientific perspective.
Thomas L. Schwartz, MD, explores...
03/18/2025
Psych Congress Network
Brittany Albright
Q&As
03/11/2025
In part 2 of this Q and A, Brittany Albright, MD, MPH, Psych Congress Elevate faculty member and founder of Sweetgrass Psychiatry, discusses 2 of her favorite anhedonia treatment strategies.
In part 2 of this Q and A, Brittany Albright, MD, MPH, Psych Congress Elevate faculty member and founder of Sweetgrass Psychiatry, discusses 2 of her favorite anhedonia treatment strategies.
In part 2 of this Q and...
03/11/2025
Psych Congress Network
Dr Brittany Albright
Q&As
03/04/2025
In this Q&A, Psych Congress Elevate faculty member Dr Brittany Albright discusses the challenging symptoms of anhedonia and its significant impact on patients' quality of life and clinical outcomes.
In this Q&A, Psych Congress Elevate faculty member Dr Brittany Albright discusses the challenging symptoms of anhedonia and its significant impact on patients' quality of life and clinical outcomes.
In this Q&A, Psych Congress...
03/04/2025
Psych Congress Network
Examining Novel Treatment Methods in Schizophrenia
Videos
02/25/2025
Christoph U. Correll, MD
In this discussion, Christoph Correll, MD, professor of psychiatry at the Zucker School of Medicine, delves into the groundbreaking FDA approval of xanomeline/tropsium chloride, a novel treatment for schizophrenia that moves beyond...
In this discussion, Christoph Correll, MD, professor of psychiatry at the Zucker School of Medicine, delves into the groundbreaking FDA approval of xanomeline/tropsium chloride, a novel treatment for schizophrenia that moves beyond...
In this discussion, Christoph...
02/25/2025
Psych Congress Network
Steven Chan, MD, MBA, FAPA, FAMIA
Videos
02/14/2025
Steven Chan, MD, MBA
In this video, Steven Chan, MD, MBA, FAPA, FAMIA, Psych Congress Steering Committee, explains some of the barriers that virtual clinicians should anticipate when weighing digital therapeutic options for major depressive disorder (MDD)...
In this video, Steven Chan, MD, MBA, FAPA, FAMIA, Psych Congress Steering Committee, explains some of the barriers that virtual clinicians should anticipate when weighing digital therapeutic options for major depressive disorder (MDD)...
In this video, Steven Chan, MD,...
02/14/2025
Psych Congress Network
Steven Chan, MD, MBA, FAPA, FAMIA
Videos
02/10/2025
Steven Chan, MD, MBA
Steven Chan, MD, MBA, FAPA, FAMIA, explains how telehealth providers can explore and adopt digital therapeutics for their virtual practices.
Steven Chan, MD, MBA, FAPA, FAMIA, explains how telehealth providers can explore and adopt digital therapeutics for their virtual practices.
Steven Chan, MD, MBA, FAPA,...
02/10/2025
Psych Congress Network
Brooke Kempf, PMHNP-BC
Videos
02/05/2025
Brooke Kempf, MSN, PMHNP-BC
What role do long-acting injectables (LAIs) play in improving long-term outcomes for patients with schizophrenia? In this discussion, Brooke Kempf, PMHNP-BC, highlights the benefits of early LAI initiation, from reducing relapse rates and...
What role do long-acting injectables (LAIs) play in improving long-term outcomes for patients with schizophrenia? In this discussion, Brooke Kempf, PMHNP-BC, highlights the benefits of early LAI initiation, from reducing relapse rates and...
What role do long-acting...
02/05/2025
Psych Congress Network
Edward Kaftarian, MD.
Videos
01/30/2025
Edward Kaftarian, MD
Edward Kaftarian, MD, shares his insights on the clinical, legal, and technological factors that impact virtual care for SUD.
Edward Kaftarian, MD, shares his insights on the clinical, legal, and technological factors that impact virtual care for SUD.
Edward Kaftarian, MD, shares...
01/30/2025
Psych Congress Network
Brooke Kempf
Videos
01/06/2025
Brooke Kempf, MSN, PMHNP-BC
Kempf emphasizes the power of patient education, addressing myths, and involving families to ease the daily medication burden. 
Kempf emphasizes the power of patient education, addressing myths, and involving families to ease the daily medication burden. 
Kempf emphasizes the power of...
01/06/2025
Psych Congress Network
Desiree Matthews, PMHNP-BC, CEO
Videos
01/06/2025
Desiree Matthews, PHMNP-BC
In this video, Desiree Matthews, PMHNP-BC, discusses how to navigate insurance policies when treating tardive dyskinesia.
In this video, Desiree Matthews, PMHNP-BC, discusses how to navigate insurance policies when treating tardive dyskinesia.
In this video, Desiree Matthews,...
01/06/2025
Psych Congress Network

Refresher Quizzes

FDA
Quiz
04/25/2024
Do you remember this FDA update?
Do you remember this FDA update?
Do you remember this FDA update?
04/25/2024
Psych Congress Network
Dr Steven Chan
Expert Insights Quiz
03/18/2025
Steven Chan, MD, MBA; Meagan Thistle
According to Psych Congress Steering Committee Member Steven Chan, MD, MBA, which of the following are important considerations when selecting and implementing digital therapeutics for the treatment of MDD?
According to Psych Congress Steering Committee Member Steven Chan, MD, MBA, which of the following are important considerations when selecting and implementing digital therapeutics for the treatment of MDD?
According to Psych Congress...
03/18/2025
Psych Congress Network
Did OUD diagnoses increase or decrease in VHA patients?
Quiz
02/25/2025
Do you remember the details of this study?
Do you remember the details of this study?
Do you remember the details of...
02/25/2025
Psych Congress Network
Charles Raison headshot
Expert Insights Quiz
02/21/2025
Charles L. Raison, MD
True or False: According to Psych Congress Steering Committee Member, Charles Raison, MD, the first-line treatment for primary insomnia is medication, including benzodiazepines.
True or False: According to Psych Congress Steering Committee Member, Charles Raison, MD, the first-line treatment for primary insomnia is medication, including benzodiazepines.
True or False: According to...
02/21/2025
Psych Congress Network
Quiz
Quiz
02/21/2025
Meagan Thistle
Is cariprazine FDA-approved as an adjunctive treatment for major depressive disorder (MDD)? What is another FDA-approved indication for this drug? Take the quiz to test your psychopharmacology knowledge!
Is cariprazine FDA-approved as an adjunctive treatment for major depressive disorder (MDD)? What is another FDA-approved indication for this drug? Take the quiz to test your psychopharmacology knowledge!
Is cariprazine FDA-approved as...
02/21/2025
Psych Congress Network
How many US Psychiatric Hospitals Provided Medications for OUD?
Quiz
02/06/2025
Do you remember the details of this study?
Do you remember the details of this study?
Do you remember the details of...
02/06/2025
Psych Congress Network
Four people ponder with question marks over their heads
Quiz
02/03/2025
Test your knowledge with this quick quiz!
Test your knowledge with this quick quiz!
Test your knowledge with this...
02/03/2025
Psych Congress Network
How many people with anxiety disorders receive treatment?
Quiz
01/28/2025
Test your statistical knowledge!
Test your statistical knowledge!
Test your statistical knowledge!
01/28/2025
Psych Congress Network
How can clinicians help patients with ADHD transition from adolescence to adulthood?
Quiz
01/22/2025
Do you remember this interview with Dr Wilens?
Do you remember this interview with Dr Wilens?
Do you remember this interview...
01/22/2025
Psych Congress Network
Three illustrated faces, one sad, one neutral, one happy, with a human hand picking up the happy face
Quiz
01/21/2025
Test your knowledge with this quiz!
Test your knowledge with this quiz!
Test your knowledge with this...
01/21/2025
Psych Congress Network
Quiz
Quiz
01/15/2025
Meagan Thistle
According to a recent study published in the Journal of Affective Disorders, what percentage of people experienced hypomanic symptoms during a major depressive disorder (MDD) episode?
According to a recent study published in the Journal of Affective Disorders, what percentage of people experienced hypomanic symptoms during a major depressive disorder (MDD) episode?
According to a recent study...
01/15/2025
Psych Congress Network